1. Field of the Invention
The present invention relates to a fixed volume prosthetic urinary bladder for use in a human being. The invention, more particularly, concerns a prosthetic urinary bladder comprising (1) a reservoir or pouch, (2) an inlet channel, (3) a vent channel having a removable cap, (4) a urethral discharge channel, and (5) a volume sensing device and an alert system. Both the inlet channel and the discharge channel may contain replaceable valves.
The present invention also relates to the surgical procedure for implantation of the prosthetic devices, including a prosthetic bladder, in a human being. In the case of prosthetic bladder implantation, this procedure also entails anastomosing the inlet channel to the upper urinary tract (kidney, ureter or intestinal segment) and the discharge channel to the lower urinary tract (urethra).
2. Description of the Prior Art
Prosthetic urinary bladders have been known for many years. A typical bladder design is disclosed in U.S. Pat. No. 3,953,897 to Chevallet et al. Such a bladder comprises a flexible pouch which expands and contracts upon introduction and discharge of urine, two inlets channels and an outlet channel connectable to the urethra.
These conventional prosthetic bladders are plagued by many problems. First, the flexible walls of the pouch which expand and contract upon introduction and discharge of urine are known to undergo structural failures. These failures are due to the stress and fatigue zones resulting from the repeated expanding and contracting forces. These structural failures appear in the form of cracks and fractures often resulting in urinary leaks. A leaking prosthetic bladder is highly undesirable and can result in adverse medical consequences for the human patient in whom the bladder is implanted.
Another problem associated with conventional prosthetic urinary bladders is the buildup of calculi in the urinary tracts. The resulting encrustation from this calculi buildup causes a flow restriction and can often serve as a source of infection.
A widespread problem encountered by many patients having prosthetic bladder implants is incontinence. The involuntary discharge of urine resulting from incontinence can cause embarrassment to the patient as well as physical discomfort and damage to the patient's clothing.
Bacterial infection is another problem that has plagued many prosthetic devices, including artificial hearts. This infection is a result of bacterial colonization on the biomaterial surface. Such bacterial infection is believed to be a major or limiting factor on the long term use of many prosthetic devices, such as the artificial heart.